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Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA)

Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA) - a Placebo Controlled Double-blind Cross-over-study

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00393614
Enrollment
30
Registered
2006-10-30
Start date
2007-05-31
Completion date
2010-03-31
Last updated
2009-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CSWS, Subclinical Sleep-Activated Epileptiform Activity

Keywords

CSWS, interiktal epileptiform activity

Brief summary

In clinical practice at the National centre for epilepsy (SSE) in Norway we see many children who have subclinical epileptiform activity in EEG that increases substantially during slow wave sleep (SSEA; subclinical sleep-activated epileptiform activity). They may or may not have seizures. Hence, according to the definition some children with SSEA do not suffer from epilepsy because they do not experience seizures. Many of these children have symptoms such as: attention deficit hyperactivity disorders (AD/HD), dyslectic problems, sleep problems, tantrums or autistic symptoms . We hypothesize that this subclinical epileptiform activity during slow sleep may act negatively on cognitive functions, language and behaviour in some children; even when the spike-wave discharges are less frequent than in CSWS (continuous spike-waves during slow sleep).

Interventions

DRUGlevetiracetam

20 mg pr. kg a day

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

* Children 5-10 years * IQ \> 50

Design outcomes

Primary

MeasureTime frame
24 hour EEGEnd of the study

Secondary

MeasureTime frame
Neuro-psychological testing,End of the study
Health related quality of lifeEnd of the study
Behavioral problemsEnd of the study

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026